Myofascial Pain Syndrome of NeckNCT04261296
Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome
A study testing dry needling, balneotherapy and dry needling +balneotherapy in people with Myofascial Pain Syndrome of Neck, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain syndrome (MAS) is a syndrome characterized by muscle spasm, tenderness, limited range of motion, stiffness, fatigue and sometimes autonomic dysfunctions accompanying pain and pain caused by trigger points in the tense bands formed in the muscles The disease is diagnosed clinically and there are many… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myofascial Pain Syndrome of Neck
- What is being tested?
- dry needling, balneotherapy and dry needling +balneotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2020to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female and male patients between the ages of 18-50 who have been diagnosed as "myofascial pain syndrome (MAS)" by clinical and examination
- Patients with cooperations who can correctly understand what is stated in the patient information form
- Patients who consent to participate in the study according to the informed voluntary consent form will be included in the study.
Who cannot join
- Presence of cervical disc hernia, radiculopathy or myelopathy
- Having tumoral, infectious, psychiatric, systemic disease and bleeding diathesis
- Stage 3-4 osteodegeneration
- Having a diagnosis of fibromyalgia syndrome according to the diagnostic criteria of 2016 American College of Rheumatology
- Presence of kyphoscoliosis
- Pregnancy
Show all 11Show fewer
- Having had previous brain, neck or shoulder surgery
- Having received treatment for MAS in the last 6 months
- Symptom onset duration is less than 3 months
- Having analgesic use for any reason
- Failure to cooperate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evran University Education and Research Hospital
Kırşehir, 40100
About this study
Myofascial pain syndrome (MAS) is a syndrome characterized by muscle spasm, tenderness, limited range of motion, stiffness, fatigue and sometimes autonomic dysfunctions accompanying pain and pain caused by trigger points in the tense bands formed in the muscles The disease is diagnosed clinically and there are many pharmacological and non-pharmacological approaches in treatment.
One of these treatments is dry needle therapy. Dry needling has been used for a long time in the treatment of myofascial pain syndrome.
Read more
Another treatment used in the treatment of myofascial pain syndrome is balneotherapy (spa treatment At Ahi Evran University Physical Therapy and Rehabilitation Center, balneotherapy is frequently used in the treatment of patients with myofascial pain syndrome.
The aim of this study is to compare the effectiveness of dry needling and balneotherapy, which has been used in the treatment of myofascial pain syndrome for many years.
Read the detailed description
Myofascial pain syndrome (MAS) is a syndrome characterized by muscle spasm, tenderness, limited range of motion, stiffness, fatigue and sometimes autonomic dysfunctions accompanying pain and pain caused by trigger points in the tense bands formed in the muscles The disease is diagnosed clinically and there are many pharmacological and non-pharmacological approaches in treatment.
One of these treatments is dry needle therapy. Dry needling has been used for a long time in the treatment of myofascial pain syndrome.
Another treatment used in the treatment of myofascial pain syndrome is balneotherapy (spa treatment At Ahi Evran University Physical Therapy and Rehabilitation Center, balneotherapy is frequently used in the treatment of patients with myofascial pain syndrome.
The aim of this study is to compare the effectiveness of dry needling and balneotherapy, which has been used in the treatment of myofascial pain syndrome for many years.
120 volunteers are planned to be included in this study. Patients will be randomly divided into 3 groups. (randomization will be done as 1: 1: 1 with a closed envelope). The patients in the first group will be given "dry needle treatment" for the aching muscle. No medication is used in this treatment.In this treatment, depending on the thickness of the adipose tissue under the skin, 13 mm, 25 mm or 30 mm long; 0.20 mm thick acupuncture needle is used. Dry needling will be done with painful trigger point and it will be waited for about 20 minutes. This treatment will be repeated once a week for 3 weeks.
Patients in the second group will be given "spa treatment". A total of 15 sessions, 20 minutes a day, 5 days a week for 3 weeks, will be held in the spa, which operates within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Both of these methods will be applied to patients in the third group.
Evaluations will be repeated before treatment, 1st week after treatment and Week 12 (3rd Month). Patients' neck range of motion (by measuring with goniometer) will be evaluated and pressure pain threshold will be measured using algometer.
Patients' pain levels will be evaluated with Visual Analogue Scale, their moods with Beck Depression Scale, anxiety levels with Beck Anxiety Scale, fear of movement with Tampa Kinesiophobia Scale, neck functions with Neck Disability Questionnaire Questionnaire, and quality of life level with SF-36 Quality of Life Scale.
In addition, the Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment. This scale is scored as "-1 = deterioration, 0 = no change, 1 = slight improvement, 2 = significant improvement and 3 = near-normal improvement". Survey applications will take approximately 10 minutes.
- Conditions
- Myofascial Pain Syndrome of Neck
- Being tested
- dry needling, balneotherapy, dry needling +balneotherapy
- Keywords
- dry needling, spa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
In this treatment, depending on the thickness of the adipose tissue under the skin, 13 mm, 25 mm or 30 mm long; 0.20 mm thick acupuncture needle is used
balneotherapyOther
Also called Spa
This treatment method; An "alert-fit" performed in a certain time interval and in a cure style by using the methods and doses of hot mineral waters, gases and peloids (sludge) from natural underground, determined in detail, repeatedly in series as bath, drinking and inhalation treatments. treatment can be defined as. There are studies showing that the effect of balneotherapy is mechanical, thermal, chemical, anti-inflammatory and immunological.
dry needling +balneotherapyOther
Both of these methods will be applied to patients in the third group.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Arm 1: Dry needling group. Dry needling will be done with painful trigger point and it will be waited for about 20 minutes. This treatment will be repeated once a week for 3 weeks.No medication is used in this treatment. Receives: Other: dry needling |
| balneotherapy | Experimental | Arm 2: Balneotherapy A total of 15 sessions, 20 minutes a day, 5 days a week for 3 weeks, will be held in the spa, which operates within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Receives: Other: balneotherapy |
| Dry needling + balneotherapy | Experimental | Arm3: dry needling + balneotherapy Both of these methods will be applied to patients in the third group. Receives: Other: dry needling +balneotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain level of the patients will be determined by "Visual Analogue Scale".
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain will be investigated.
Secondary outcomes (7)
Mood of the patients
Mood of the patients will be determined by using "Beck Depression Scale".
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the mood of patients will be investigated.
Pressure pain threshold
Pressure pain threshold will be measured in patients using algometer.
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain pressure threshold will be investigated.
Anxiety level of the patients
Anxiety level of the patients will be determined by using "Beck Anxiety Scale"
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the anxiety will be investigated.
Quality of life of the patients
Anxiety level of the patients will be determined by using "Short Form-36 Quality of Life. Scale"
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the quality of life will be investigated.
Kinesiophobia of the patients
Anxiety level of the patients will be determined by using "Tampa Kinesiophobia Scale".
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of kinesiophobia will be investigated.
Disability level of the patients
Disability level of the patients will be determined by using "Neck Disability Questionnaire".
Measured: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of disablity will be investigated.
Global Assesment of the patients
Global Assesment of the patients will be determined by using "Global Assessment Scale".
Measured: The Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start10 Feb 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Syndrome of NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Karakuzu Güngör, Ahi Evran University Education and Research Hospital
- Investigators
- Zeynep Karakuzu Güngör, MD, Principal investigator, Ahi Evran Unıversity Faculty of MedicineFatmanur Aybala Koçak, MD, Study director, Ahi Evran Unıversity Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261296
- Sponsor's protocol ID
- 2019-22/217
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I believe that the study results will be beneficial to the world of science.
Publications
Ong J, Claydon LS. The effect of dry needling for myofascial trigger points in the neck and shoulders: a systematic review and meta-analysis. J Bodyw Mov Ther. 2014 Jul;18(3):390-8. doi: 10.1016/j.jbmt.2013.11.009. Epub 2013 Nov 9.
PubMed 25042309
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT04261296
- Acronym / sponsor ID
- 2019-22/217
- Conditions
- Myofascial Pain Syndrome of Neck
- Keywords
- dry needling, spa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Myofascial pain syndrome (MAS) is a syndrome characterized by muscle spasm, tenderness, limited range of motion, stiffness, fatigue and sometimes autonomic dysfunctions accompanying pain and pain caused by trigger points in the tense bands formed in the muscles The disease is diagnosed clinically and there are many pharmacological and non-pharmacological approaches in treatment.
One of these treatments is dry needle therapy. Dry needling has been used for a long time in the treatment of myofascial pain syndrome.
Another treatment used in the treatment of myofascial pain syndrome is balneotherapy (spa treatment At Ahi Evran University Physical Therapy and Rehabilitation Center, balneotherapy is frequently used in the treatment of patients with myofascial pain syndrome.
The aim of this study is to compare the effectiveness of dry needling and balneotherapy, which has been used in the treatment of myofascial pain syndrome for many years.
Detailed description
Myofascial pain syndrome (MAS) is a syndrome characterized by muscle spasm, tenderness, limited range of motion, stiffness, fatigue and sometimes autonomic dysfunctions accompanying pain and pain caused by trigger points in the tense bands formed in the muscles The disease is diagnosed clinically and there are many pharmacological and non-pharmacological approaches in treatment.
One of these treatments is dry needle therapy. Dry needling has been used for a long time in the treatment of myofascial pain syndrome.
Another treatment used in the treatment of myofascial pain syndrome is balneotherapy (spa treatment At Ahi Evran University Physical Therapy and Rehabilitation Center, balneotherapy is frequently used in the treatment of patients with myofascial pain syndrome.
The aim of this study is to compare the effectiveness of dry needling and balneotherapy, which has been used in the treatment of myofascial pain syndrome for many years.
120 volunteers are planned to be included in this study. Patients will be randomly divided into 3 groups. (randomization will be done as 1: 1: 1 with a closed envelope). The patients in the first group will be given "dry needle treatment" for the aching muscle. No medication is used in this treatment.In this treatment, depending on the thickness of the adipose tissue under the skin, 13 mm, 25 mm or 30 mm long; 0.20 mm thick acupuncture needle is used. Dry needling will be done with painful trigger point and it will be waited for about 20 minutes. This treatment will be repeated once a week for 3 weeks.
Patients in the second group will be given "spa treatment". A total of 15 sessions, 20 minutes a day, 5 days a week for 3 weeks, will be held in the spa, which operates within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Both of these methods will be applied to patients in the third group.
Evaluations will be repeated before treatment, 1st week after treatment and Week 12 (3rd Month). Patients' neck range of motion (by measuring with goniometer) will be evaluated and pressure pain threshold will be measured using algometer.
Patients' pain levels will be evaluated with Visual Analogue Scale, their moods with Beck Depression Scale, anxiety levels with Beck Anxiety Scale, fear of movement with Tampa Kinesiophobia Scale, neck functions with Neck Disability Questionnaire Questionnaire, and quality of life level with SF-36 Quality of Life Scale.
In addition, the Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment. This scale is scored as "-1 = deterioration, 0 = no change, 1 = slight improvement, 2 = significant improvement and 3 = near-normal improvement". Survey applications will take approximately 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: dry needlingArm 1: Dry needling group. Dry needling will be done with painful trigger point and it will be waited for about 20 minutes. This treatment will be repeated once a week for 3 weeks.No medication is used in this treatment. |
| balneotherapy | Experimental | Other: balneotherapyArm 2: Balneotherapy A total of 15 sessions, 20 minutes a day, 5 days a week for 3 weeks, will be held in the spa, which operates within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. |
| Dry needling + balneotherapy | Experimental | Other: dry needling +balneotherapyArm3: dry needling + balneotherapy Both of these methods will be applied to patients in the third group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female and male patients between the ages of 18-50 who have been diagnosed as "myofascial pain syndrome (MAS)" by clinical and examination
- Patients with cooperations who can correctly understand what is stated in the patient information form
- Patients who consent to participate in the study according to the informed voluntary consent form will be included in the study.
Key exclusion criteria (11 listed)
- Presence of cervical disc hernia, radiculopathy or myelopathy
- Having tumoral, infectious, psychiatric, systemic disease and bleeding diathesis
- Stage 3-4 osteodegeneration
- Having a diagnosis of fibromyalgia syndrome according to the diagnostic criteria of 2016 American College of Rheumatology
- Presence of kyphoscoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingIn this treatment, depending on the thickness of the adipose tissue under the skin, 13 mm, 25 mm or 30 mm long; 0.20 mm thick acupuncture needle is used | Other | Dry needling |
| balneotherapyAlso: SpaThis treatment method; An "alert-fit" performed in a certain time interval and in a cure style by using the methods and doses of hot mineral waters, gases and peloids (sludge) from natural underground, determined in detail, repeatedly in series as bath, drinking and inhalation treatments. treatment can be defined as. There are studies showing that the effect of balneotherapy is mechanical, thermal, chemical, anti-inflammatory and immunological. | Other | balneotherapy |
| dry needling +balneotherapyBoth of these methods will be applied to patients in the third group. | Other | Dry needling + balneotherapy |
Primary outcome
Visual Analogue Scale
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain will be investigated.
Pain level of the patients will be determined by "Visual Analogue Scale".
7 secondary outcomes
Mood of the patients
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the mood of patients will be investigated.
Pressure pain threshold
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain pressure threshold will be investigated.
Anxiety level of the patients
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the anxiety will be investigated.
Quality of life of the patients
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the quality of life will be investigated.
Kinesiophobia of the patients
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of kinesiophobia will be investigated.
Disability level of the patients
Time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of disablity will be investigated.
Global Assesment of the patients
Time frame: The Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 25042309Ong J, Claydon LS. The effect of dry needling for myofascial trigger points in the neck and shoulders: a systematic review and meta-analysis. J Bodyw Mov Ther. 2014 Jul;18(3):390-8. doi: 10.1016/j.jbmt.2013.11.009. Epub 2013 Nov 9.
- Individual participant dataSharing planned: No. I believe that the study results will be beneficial to the world of science.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Karakuzu Güngör, MD principal investigator
Ahi Evran Unıversity Faculty of Medicine
Fatmanur Aybala Koçak, MD study director
Ahi Evran Unıversity Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling, balneotherapy and dry needling +balneotherapy in people with Myofascial Pain Syndrome of Neck, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain will be investigated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.